Comparing a new treatment for menopause-related vaginal health issues to standard estrogen therapy

The Efficacy of the Use of Cellular Matrix / A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms/g Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer.

This study is testing a new treatment for menopause-related vaginal health issues to see if it works as well as the standard estrogen therapy for women who are sexually active.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fundacion Dexeus (other)
• Drugs / interventions: radiation
• Locations: 1 site (Barcelona)
• Trial ID: NCT06425978 on ClinicalTrials.gov

What this trial studies

This interventional trial evaluates the effectiveness of the Cellular Matrix/A-CP-HA Kit, which combines autologous platelet-rich plasma and non-cross-linked hyaluronic acid, against standard local estrogen therapy in treating genitourinary syndrome of menopause (SGM) in sexually active women. A total of 192 participants will be randomly assigned to receive either the new treatment or the control for a duration of 24 months, with follow-up assessments at 3 and 6 months post-treatment. The study aims to determine if the new treatment is non-inferior to the standard therapy based on various validated scales and symptom records.

Who should consider this trial

Good fit: Ideal candidates are sexually active women under 70 years old who have been menopausal for at least 12 months and exhibit symptoms of SGM with a vaginal health index score below 15.

Not a fit: Patients currently undergoing systemic or local hormonal treatments, or those with specific contraindications or recent pelvic surgeries, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, effective option for improving vaginal health in menopausal women suffering from SGM.

How similar studies have performed: While this approach is innovative, it builds on existing treatments for SGM, and similar studies have shown promise in using platelet-rich plasma for various conditions.

Eligibility criteria

Inclusion Criteria:

* Women ≤70 years old
* Women that are sexually active
* Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \< 15 points.
* Women who understand the Spanish language
* Willing to participate in the study and sign informed consent.

Exclusion Criteria:

* Systemic or local hormonal treatment in the last 3 months
* Tamoxifen or Aromatase inhibitor treatments
* Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy
* Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases.
* Women who have had pelvic surgery within 6 months.
* Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.

Where this trial is running

Barcelona

• Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona, Spain (RECRUITING)

Study contacts

• Study coordinator: Antonella de Ponte Davi, MD

Conditions: Genitourinary Syndrome of Menopause